Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
Phase II Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
2 other identifiers
interventional
124
11 countries
51
Brief Summary
This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe ulcerative colitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2011
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2011
CompletedFirst Posted
Study publicly available on registry
April 18, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedAugust 12, 2016
August 1, 2016
1 year
April 14, 2011
August 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point
Week 10
Secondary Outcomes (3)
Clinical response as defined by at least a 3-point decrease and 30% reduction from baseline in MCS and a >/=1-point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1
Week 6 and Week 10
Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point
Week 6
Proportion of patients with endoscopic score and rectal bleeding score of 0
Week 6 and Week 10
Study Arms (2)
rhuMAb Beta7
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of moderate to severe ulcerative colitis outpatient
- Disease duration at time of screening of \>/= 12 weeks
You may not qualify if:
- Extensive colonic resection or subtotal or total colectomy
- Presence of an ileostomy or colostomy
- Moderate to severe anemia
- A history or evidence of colonic mucosal dysplasia
- Pregnant or lactating
- Significant uncontrolled co-morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal (GI) disorders
- Significant screening ECG abnormalities, including evidence of acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block
- Poorly controlled diabetes
- Impaired renal function
- Impaired hepatic function in the absence of a diagnosis of primary sclerosing cholangitis
- Positive tests for antibodies indicating active or prior infection with HIV or hepatitis B (HBV) or C (HCV)
- Positive screening test for latent mycobacterium tuberculosis (TB) infection
- Demyelinating disease
- Received any investigational treatment within 12 weeks prior to initiation of study treatment
- Previous exposure to rhuMAb Beta7
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (51)
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
Gainesville, Florida, 32610, United States
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Atlanta, Georgia, 30308, United States
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Chevy Chase, Maryland, 20815, United States
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Ann Arbor, Michigan, 48109-0682, United States
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Rochester, Minnesota, 55905, United States
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Great Neck, New York, 11021, United States
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Cincinnati, Ohio, 45219, United States
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Garran, Australian Capital Territory, 2605, Australia
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Clayton, Victoria, 3168, Australia
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Fitzroy, Victoria, 3065, Australia
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Melbourne, Victoria, 3181, Australia
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Parkville, Victoria, 3050, Australia
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Bonheiden, 2820, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Edmonton, Alberta, T6G 2X8, Canada
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Edmonton, Alberta, V6Z 1Y6, Canada
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London, Ontario, N6A 5W9, Canada
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Woodbridge, Ontario, L4L 4Y7, Canada
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Hradec Králové, 500 12, Czechia
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Náchod, 547 01, Czechia
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Ostrava - Poruba, 708 52, Czechia
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Zlín, 762 75, Czechia
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Berlin, 13353, Germany
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Hanover, 30625, Germany
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Kiel, 24105, Germany
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Minden, 32423, Germany
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Ulm, 89081, Germany
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Budapest, 1073, Hungary
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Budapest, 1136, Hungary
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Gyöngyös, 3200, Hungary
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Győr, 9024, Hungary
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Mosonmagyaróvár, 9200, Hungary
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Beersheba, 84105, Israel
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Haifa, 31096, Israel
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Jerusalem, 91031, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 64239, Israel
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Auckland, 1023, New Zealand
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Auckland, 1640, New Zealand
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Christchurch, 8011, New Zealand
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Dunedin, 9054, New Zealand
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Takapuna, 0620, New Zealand
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Barcelona, Barcelona, 08003, Spain
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Barcelona, Barcelona, 08036, Spain
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Harrow, HA1 3UJ, United Kingdom
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London, N6A 4L6, United Kingdom
Unknown Facility
London, SW10 9NH, United Kingdom
Unknown Facility
Newcastle upon Tyne, NE1 4LP, United Kingdom
Related Publications (1)
Vermeire S, O'Byrne S, Keir M, Williams M, Lu TT, Mansfield JC, Lamb CA, Feagan BG, Panes J, Salas A, Baumgart DC, Schreiber S, Dotan I, Sandborn WJ, Tew GW, Luca D, Tang MT, Diehl L, Eastham-Anderson J, De Hertogh G, Perrier C, Egen JG, Kirby JA, van Assche G, Rutgeerts P. Etrolizumab as induction therapy for ulcerative colitis: a randomised, controlled, phase 2 trial. Lancet. 2014 Jul 26;384(9940):309-18. doi: 10.1016/S0140-6736(14)60661-9. Epub 2014 May 9.
PMID: 24814090DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sharon O'Byrne, M.D.
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2011
First Posted
April 18, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2012
Study Completion
June 1, 2013
Last Updated
August 12, 2016
Record last verified: 2016-08